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safinamide

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Michael J Fox Foundation awards Koneksa second research grant

The grant will be used to evaluate whether digital biomarkers can help to predict the different stages of Parkinson’s disease

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AstraZeneca and Daiichi Sankyo get FDA approval for breast cancer drug

Results from a phase 3 trial showed Enhertu reduced the risk of disease progression or death by 50%

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Bayer’s Nubeqa receives FDA approval to treat metastatic prostate cancer

The risk of death was reduced by 32% by adding the drug to standard therapy

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Janssen’s Stelara approved by FDA for psoriatic arthritis in paediatric patients

Active psoriatic arthritis affects 5-8% of children and adolescents with chronic inflammatory arthritis

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Arcutis receives FDA approval for steroid-free plaque psoriasis treatment

Zoryve is the first and only PDE4 inhibitor approved for plaque psoriasis

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Sarepta to submit application for Duchenne muscular dystrophy gene therapy

The condition occurs in approximately one in every 3,500-5,000 newborn males worldwide

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FDA grants priority review to Biogen’s tofersen for genetic form of ALS

The approval follows a failed phase 3 study, but the treatment showed promise in patients with SOD1-ALS

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AstraZeneca’s Tezspire recommended for approval in the EU by CHMP

The recommendation is for the treatment of severe asthma as an add-on therapy for patients 12 years and above

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Sandoz’s biosimilar medicine application accepted by FDA

If approved, the higher concentration formulation could decrease the number of injections required for patients currently receiving a lower dose of Hyrimoz

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FDA approves Incyte’s Opzelura for vitiligo

It is the first and only FDA-approved product for repigmentation in patients with nonsegmental vitiligo

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Roche’s diagnostic test for Alzheimer’s receives FDA Breakthrough Device Designation

Alzheimer's affects more than 55 million people globally and is the most common form of dementia

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FDA grants Novavax’s COVID-19 vaccine emergency use authorisation for adults

The decision was based on data from a phase 3 trial which showed the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19

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